Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts. Aurigene has pioneered a unique, collaborative business model to work with pharma and biotech partners, in a win-win partnership that combines Aurigene’s deep expertise in oncology and inflammation, with our collaboration partners’ needs for expertise, scalability and high-quality, quick and cost-effective prosecution of targets.
Post: Group Leader/Sr. Group Leader- Pharmaceutical Development
Job description
- Should have thorough scientific/technical expertise to lead and mentor peers & reportees towards pharmaceutical development of NCEs for regulatory (GLP) toxicity studies and non-regulatory non-clinical pharmacokinetic, efficacy and toxicity studies.
- Should be able to create a list of pre-requisites/filters from Pharmaceutical development point-of-view for NCE to pass through various stages of drug discovery & development.
- Should be able to characterize and screen physical forms, including stability profile; investigate pre-formulation, and come-up with alternative drug delivery strategies as and when required.
- Should be able to advice the chemistry & biology teams about the drug-ability of NCEs from Pharmaceutical development point-of-view and be able to support the project progression.
- Should have a commendable communication & inter-personal skills as the job requires representing function in cross-functional meetings & meetings across the organizations.
- Should closely work with business teams in bringing new customers/clients to the function or organization & should be able to interface business teams & external clients to crystallize project proposals & execution.
- Should be able to prepare and review protocols, guidelines, SOPs for lab equipments/instruments and processes.
- Should lead & encourage peers & reportees in developing & maintaining new processes and systems in the functional area to enhance the productivity/efficiency.
- Should have a commendable understanding of systems and process pertaining to safety, health and environment.
Candidate Profile
- Ph.D in Pharmaceutics/Pharmaceutical Technology with 8-10 years of experience or M.Pharm. in Pharmaceutics/Pharmaceutical Technology with 12- 14 years experience in NCE pre-formulation and formulation development.
- Should be thorough with different stages of drug discovery & development especially pre-clinical development stages and IND-enabling studies.
- Should be well versed with the guidance documents pertaining to Quality and Pharmaceutical Development.
- Should be able to lead an innovative team, design project experiments and overall direction, and be able to communicate results and challenges to key stakeholders.
Additional Information:
Qualification: M.Pharm, Ph.D
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Other
Location: Hyderabad
End Date: 31st September, 2015
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